Press Release
RENOVO ANNNOUNCES JUVISTA® PHASE 2 TRIAL RESULTS IN SCAR REVISION AND BREAST AUGMENTATION SURGERY
03 Mar 2008 - Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing drugs for the reduction of scarring and acceleration of healing, today announces two Phase 2 clinical trial results for its lead drug, Juvista (human recombinant TGFß3) in scar revision (RN1001-1009) and breast augmentation (RN1001-1010) surgery.
Summary
Renovo is pleased to announce the scar revision trial, where Juvista was dosed twice, met its primary endpoint with statistical significance. The breast augmentation trial, where Juvista was dosed once, did not meet its primary endpoint. In view of this new data and previous trials that have already reported Renovo believes that Juvista’s efficacy is greater when administered twice.
Based on these results Renovo plans to commence the European Phase 3 programme with a scar revision surgery trial. As previously guided, this first European Phase 3 trial will start in the second half of 2008. Two dose levels of Juvista are likely to be tested (200ng and 500ng) given twice, the first at the time of surgery following wound closure and the second 24 hours later. Scar revision is a procedure performed by Plastic Surgeons and Cosmetic Dermatologists for both patients wanting cosmetic improvements and those with serious disfiguring scars.
Renovo will provide guidance on the design of this trial and the remainder of the Phase 3 programme for the European Regulatory Filing/Dossier following further consultation with both Shire and the relevant regulatory authorities
Renovo’s strategy remains firmly focussed on accessing all segments of the substantial global market for the reduction of scarring in the skin. Accordingly Renovo is currently working to update its Juvista clinical development and commercialisation plans in order to achieve this objective.
The Company is well funded (net cash position at 31 December 2007: £93.8m) and has a broad portfolio of drugs with different mechanisms of action. Zesteem®, Renovo’s lead drug for the acceleration of wound healing in the skin, will report Phase 3 clinical data in the second half of 2008.

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